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Treatment of Unresecable and/or Metastatic Merkel Cell Carcinoma by Somatostatine Analogues (PHRC-Merkel)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02351128
Recruitment Status : Completed
First Posted : January 30, 2015
Last Update Posted : October 18, 2017
Information provided by (Responsible Party):
University Hospital, Grenoble

Brief Summary:

The purpose of this trial is to evaluate the efficacy of lanreotide on locally evolving and/or metastatic MCC in a national prospective multicentre phase II study (centres belonging to the skin cancer task force of the French Society of Dermatology namely "Groupe de Cancérologie Cutanée de la Société Française de Dermatologie"). This one-arm study, for which the primary endpoint is overall response to lanreotide, will follow an A'Hern plan in one step (A'Hern RP. Sample size tables for exact single-stage phase II designs. Stat Med 2001, 20:859-66) with main evaluation at 12 weeks on a population of 35 patients. The investigators make assumption that a 40% success rate at 3 months would be desirable, but if it was 20% or less the treatment would be unacceptable. It gives a trial size of 35 patients with a cut-off of 12 patients. Over 12 patients lanreotide will be considered as effective.

The lanreotide treatment (Somatuline LP 120 mg injected subcutaneously every 28 days) will be provided by IPSEN Pharma laboratory. An ancillary immunohistochemistry study on somatostatine receptors 2,3,5, dopamine receptors 1,2 and polyomavirus MCPyV will bring new data on this neuroendocrine tumour and potentially provide new therapeutic perspectives.

The results of this study may :

  • determine whether somatostatin analogues may help to treat locally advanced and/or metastatic MCC;
  • address whether there is a correlation between positive SPECT-CT (octreoscan) assessment and therapeutic response to lanreotide;
  • evaluate the place of TEP-CT and SPECT-CT for MCC evaluation/staging;
  • evaluate in future studies, with the ancillary data, other analogues or hybrid molecules;
  • consider, if positive results are obtained from this study, somatostatin analogues as adjuvant treatment after surgery of primary MCC.

Condition or disease Intervention/treatment Phase
Carcinoma, Merkel Cell Drug: Lanreotide Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 35 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Traitement Des Carcinomes à Cellules de Merkel inopérables et/ou métastatiques Par Analogue de la Somatostatine - Etude Nationale Multicentrique Mono-bras de Phase II.
Study Start Date : April 2015
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : May 15, 2017

Arm Intervention/treatment
Experimental: Only one arm
All patients receive Lanreotide.
Drug: Lanreotide
Other Name: Somatuline

Primary Outcome Measures :
  1. Percentage of patient with positive response according to the RECIST 1.1 criteria [ Time Frame: at 3 months ]
    Positive response will be defined according to the RECIST 1.1 criteria

Secondary Outcome Measures :
  1. Percentage of patient with positive response according to the RECIST 1.1 criteria [ Time Frame: at 6, 9,12,18 and 24 months ]
    Positive response will be defined according to the RECIST 1.1

  2. Number of Participants with Adverse Events [ Time Frame: at 3,6, 9,12,18 and 24 months ]
    Description of the safety and tolerability of lanreotide in this study

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Histologically confirmed neuroendocrine carcinoma of the skin (Merkel cell carcinoma) with inoperable local-regional disease or distant metastatic disease (stages IIIB or IV AJCC 2010), cerebral nervous system metastases will be allowed.
  • First line of treatment or more
  • Measurable disease: at least 20 mm by conventional techniques or 10 mm by spiral CT scan
  • WHO performance status ECOG 0-3
  • premenopausal patients must use effective contraception
  • No other prior malignancy within 5 years except adequately treated basal cell or squamous cell carcinoma or in situ cancer of the cervix
  • No other concurrent chemotherapy, immunotherapy or hormone therapy.
  • At least 4 weeks since adjuvant chemotherapy, 14 days since radiotherapy and 2 weeks since surgery
  • Biological functions: absolute neutrophil count at least 1000/mm3, platelet count at least 100000/mm3, haemoglobin at least 9g/dl (transfusion allowed), bilirubin no greater than 3 times upper limit of normal (ULN), SGOT and SGPT no greater than 2.5 times ULN, no untreated chronic liver disease, creatinine no greater than 1.5 times ULN, no untreated chronic renal disease, no untreated diabetes or infection
  • Written informed consent

Exclusion Criteria:

  • previous hypersensibility to lanreotide treatment
  • complicated and untreated cholelithiasis
  • pregnancy or breast-feeding
  • patient treated with cyclosporine

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02351128

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Grenoble University Hospital
Grenoble, France, 38 000
Sponsors and Collaborators
University Hospital, Grenoble
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Principal Investigator: BEYLOT-BARY Marie Bordeaux University Hospital, Haut-lévêque
Principal Investigator: DUTRIAUX Carole Bordeaux University Hospital, St André
Principal Investigator: DALAC Sophie Dijon University Hospital
Principal Investigator: DUPUY Alain Rennes University Hospital
Principal Investigator: LEBBE Céleste AP-HP- Saint Louis
Principal Investigator: AVRIL Marie-Françoise AP-HP - Cochin
Principal Investigator: DALLE Stéphane HCL- Lyon Sud, Pierre Bénite
Principal Investigator: GUILLOT Bernard Montpellier University Hospital
Principal Investigator: VERNEUIL Laurence University Hospital, Caen
Principal Investigator: DRENO Brigitte Nantes University Hospital
Principal Investigator: HAINAUT-Wierzbicka Ewa Poitiers University Hospital
Principal Investigator: GROB Jean-Jacques AP-HM
Principal Investigator: DEQUATREBARBES Julie Annecy Interregional Hospital
Principal Investigator: ZEHOU Ouidad AP-HP-Henri MONDOR
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Responsible Party: University Hospital, Grenoble Identifier: NCT02351128    
Other Study ID Numbers: 38RC14.040
2014-001273-13 ( EudraCT Number )
First Posted: January 30, 2015    Key Record Dates
Last Update Posted: October 18, 2017
Last Verified: October 2017
Keywords provided by University Hospital, Grenoble:
Additional relevant MeSH terms:
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Carcinoma, Merkel Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Antineoplastic Agents